Autosomal Dominant Polycystic Kidney Disease
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EMA approval · 2026-08-19EMA Authorised: Jinarc (tolvaptan) — Otsuka Pharmaceutical Netherlands B.V.
Authorised status for Jinarc (tolvaptan) for polycystic kidney disease due to autosomal dominant inheritance, implemented by Otsuka Pharmace…
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EMA approval · 2025-08-08EMA Authorised: Jinarc (tolvaptan) — Otsuka Pharmaceutical Netherlands B.V.
The EMA has authorised Jinarc (tolvaptan) for autosomal dominant polycystic kidney disease under the MAH Otsuka Pharmaceutical Netherlands B…
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FDA approval · 2025-04-23FDA Approved: JYNARQUE — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
FDA approved a supplemental application for JYNARQUE (tolvaptan) submitted by Otsuka America Pharmaceutical, Inc. The action pertains to a s…
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FDA approval · 2024-12-16FDA Approved: JYNARQUE — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
FDA approved a supplemental application for JYNARQUE (tolvaptan) from Otsuka America Pharmaceutical, potentially updating or expanding its l…
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FDA approval · 2023-09-29FDA Approved: JYNARQUE — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
The FDA approved a supplemental application for JYNARQUE (tolvaptan) submitted by Otsuka America Pharmaceutical, Inc.
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FDA approval · 2020-11-25FDA Approved: JYNARQUE — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
FDA approved a supplemental application for JYNARQUE (tolvaptan) by Otsuka America Pharmaceutical, expanding labeling to cover a new indicat…
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FDA approval · 2020-10-19FDA Approved: JYNARQUE — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
FDA approved a supplemental application for JYNARQUE (tolvaptan) by Otsuka America Pharmaceutical, Inc. The approval expands regulatory auth…
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FDA approval · 2019-12-03FDA Approved: JYNARQUE — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
The FDA approved a supplemental application for JYNARQUE (tolvaptan) submitted by Otsuka America Pharmaceutical, Inc., authorizing an additi…
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FDA approval · 2018-07-30FDA Approved: JYNARQUE — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
The FDA approved a supplemental application for JYNARQUE (tolvaptan) from Otsuka America Pharmaceutical, Inc. The action concerns autosomal …
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FDA approval · 2018-04-23FDA Approved: JYNARQUE — Original Application (Otsuka America Pharmaceutical, Inc.)
The FDA approved JYNARQUE (tolvaptan) from Otsuka for autosomal dominant polycystic kidney disease, marking the first drug approved to slow …